Device recall
Z-2334-2008: ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The…
FDA device recall · Class II · Bio-Detek, Inc.
Key facts
| Recall number (Z-number) | Z-2334-2008 |
|---|---|
| Recall event | 48753 |
| Product | ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring. |
| Product code | MLN |
| Recalling firm | Bio-Detek, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2016 |
| 510(k) numbers | K051076 |
| FEI number | 1218058 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database